Follicular LymphomaPhase 2GAUDEALISNCT03890289
Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma
A Phase 2 study testing Idelalisib and Obinutuzumab in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 4 sites in Italy.
Trial summary
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Idelalisib and Obinutuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesItaly
- Study dates
- 18 Oct 2019to 10 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory, histologically confirmed CD20-positive follicular non-Hodgkin's lymphoma, grade 1, 2 or 3a according to WHO 2017 classification.
- Age 18 ≥ years
- At least 2 prior systemic therapies for follicular lymphoma including both any antibody directed against the CD20 antigen and a chemotherapy combination.
- Treatment indications, with the presence of at least one of the following:
- bulky disease (nodal or extranodal mass - except spleen -more than 7 cm in its greater diameter or involvement of at least 3 nodal or extranodal sites, each with a diameter equal to or greater than 3 cm);
- at least one B-symptom (fever > 38°C of unclear etiology, night sweats, weight loss greater than 10% of body weight in the prior 6 months);
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- symptomatic splenomegaly;
- compression syndrome (i.e. of orbits, ureters, gastrointestinal tract, biliary tract);
- lymphoma-related cytopenias (hemoglobin < 10 g/dL and/or platelets < 100.000/mmc and/or neutrophils < 1.500/mmc);
- pleural or peritoneal serous effusions;
- lactate dehydrogenase elevation.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- Adequate hematological function, unless abnormalities due to underlying disease, within 28 days prior to signing informed consent, defined as follows: neutrophils > 1.500/mmc, platelets > 75.000/mmc, hemoglobin > 8,0 g/dL with transfusion independence.
- Capacity and willingness to adhere to study visit schedule and specific protocol procedures.
- Willingness to sign a written informed consent.
- Compliance with effective contraception without interruption, from 28 days before treatment start up (i.e., during the screening phase) to 18 months after treatment discontinuation, agreeing not to donate the semen during treatment and for 18 months after discontinuation (if the patient is male), or to undergo ongoing pregnancy test during the course of the study (if the patient is female).
- Patients must agree to undergo JPJ prophylaxis throughout the treatment period and 2-6 months thereafter (before consulting with Medical Monitor).
Who cannot join
- Grade 3b follicular non-Hodgkin's lymphoma or evidence of transformation to high-grade non-Hodgkin's lymphoma.
- Central nervous system or leptomeningeal involvement by lymphoma.
- Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent.
- Seropositivity for HBV or evidence of active infection (HBsAg positivity, or HBsAg negativity with positive anti-HBs/anti-HBc and detectable viral DNA load); if viral load is negative or undetectable, the patient is eligible, provided their HBsAg negativity.
- Positive viral HCV RNA
- Seropositivity for HIV, regardless of viral load.
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- Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension
- Known history of drug induced pneumonitis
- On-going inflammatory bowel disease
- On-going alcohol or drug addiction
- Life expectancy lower than 6 months.
- Prior history of malignancies, other than follicular lymphoma, unless the patient has been free for at least 10 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix).
- Any of the following laboratory abnormalities: liver enzymes (AST/SGOT and/or ALT/SGPT) > 2.5-fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin > 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance < 30 mL/min.
- Uncontrolled intercurrent illness.
- Known hypersensitivity or allergy to murine products or to any of the medicaments under investigation.
- Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception.
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study.
- Any evidence of ongoing bacterial, viral and fungal infection.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Bologna, 40138
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, 50141
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara, 28100
Azienda sanitaria-universitaria integrata Trieste (ASUITS) - SC Ematologia
Trieste, 34121
About this study
Official title: Idelalisib Plus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: a Phase 2, Single-arm, Multicentric Study
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.
Read the detailed description
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.
Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15 of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab and on a daily 150 mg bid schedule. For patients achieving at least a partial response at the end of induction, a maintenance phase with obinutuzumab is scheduled (on day 1 every two months for two years or until progression or unacceptable toxicity, whichever comes first) If one of the two drugs has to be permanently discontinued due to any cause, patient may continue treatment with the other agent if it is judged to be a clinical benefit. Patients with at least a stable disease will enter the follow-up phase and will be followed with repeated CT scans every six months for two years or until death/progression occurs (whichever comes firsts).
Patients with progressive disease, whenever progression is documented, will enter a survival follow up period of two years after PD was documented. These patients are however considered evaluable for OS.
- Conditions
- Follicular Lymphoma
- Being tested
- Idelalisib, Obinutuzumab
- Keywords
- Idelalisib, Obinutuzumab, Relapsed/Refractory Follicular Lymphoma
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
ObinutuzumabDrug
Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib Plus Obinutuzumab | Experimental | Single arm: Regimen: GAUDEALIS q28 days
* Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle)
* Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward)
* Idelalisib Dose: 150 mg BID oral Daily (24 weeks) Receives: Drug: Idelalisib; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint - Overall Response Rate (ORR)
Investigator's assessed Overall response rate at the end of induction phase of patients treated with a chemo-free combination with obinutuzumab and idelalisib. Overall response rate is defined as the proportion of patients with at least a partial response according with 2014 Lugano criteria.
Measured: Six months after the start of treatment
Secondary outcomes (3)
Secondary Endpoints 1 - Overall Survival (OS) Rate
Overall survival (OS) rate, measured from the date of starting therapy to the date of death from any cause. Patients alive and patients who are lost to follow up at the time of the final analysis will be censored at the date of the last contact.
Measured: Up to 24 months from the start of treatment
Secondary Endpoints 2 - Progression-free Survival (PFS) Rate
Progression-free survival (PFS) rate: measured from the date of starting therapy to the date of disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date. Patients who will have no tumor assessment after the start of therapy due to interruption of both drugs will be considered failures at the date of treatment interruption in the PFS analysis
Measured: Up to 24 months from the start of treatment
Secondary Endpoints 3 - Patients' Withdrawal Rate
patients' withdrawal rate, incidence and nature of any severe adverse events hospitalization rate throughout the study, and patients' compliance to oral treatment, incidence of any adverse events occurring during and right after treatment
Measured: Up to 24 months from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start18 Oct 2019
- Primary completion29 Apr 2021
- Study completion10 May 2023
Why it stopped: Study was halted prematurely due to safety, since tocity stopping rules have been met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm: Regimen: GAUDEALIS q28 days * Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle) * Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward) * Idelalisib Dose: 150 mg BID oral Daily (24 weeks) Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15, of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles in total (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab on a daily 150 mg bid schedule orally and continuously (24 weeks).
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierluigi Zinzani, Prof., Principal investigator, Bologna - Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890289
- Sponsor's protocol ID
- FIL_GAUDEALIS
- Acronym
- GAUDEALIS
- Status last verified
- Jul 2023
- First submitted
- 21 Mar 2019
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idelalisib Plus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: a Phase 2, Single-arm, Multicentric Study
- ClinicalTrials.gov ID
- NCT03890289
- Acronym / sponsor ID
- GAUDEALIS / FIL_GAUDEALIS
- Conditions
- Follicular Lymphoma
- Keywords
- Idelalisib, Obinutuzumab, Relapsed/Refractory Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted prematurely due to safety, since tocity stopping rules have been met
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.
Detailed description
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.
Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15 of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab and on a daily 150 mg bid schedule. For patients achieving at least a partial response at the end of induction, a maintenance phase with obinutuzumab is scheduled (on day 1 every two months for two years or until progression or unacceptable toxicity, whichever comes first) If one of the two drugs has to be permanently discontinued due to any cause, patient may continue treatment with the other agent if it is judged to be a clinical benefit. Patients with at least a stable disease will enter the follow-up phase and will be followed with repeated CT scans every six months for two years or until death/progression occurs (whichever comes firsts).
Patients with progressive disease, whenever progression is documented, will enter a survival follow up period of two years after PD was documented. These patients are however considered evaluable for OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm: Regimen: GAUDEALIS q28 days * Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle) * Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward) * Idelalisib Dose: 150 mg BID oral Daily (24 weeks) Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15, of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles in total (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab on a daily 150 mg bid schedule orally and continuously (24 weeks).
| Arm | Type | Receives |
|---|---|---|
| Idelalisib Plus Obinutuzumab | Experimental | Drug: Idelalisib, Drug: ObinutuzumabSingle arm: Regimen: GAUDEALIS q28 days * Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle) * Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward) * Idelalisib Dose: 150 mg BID oral Daily (24 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Relapsed or refractory, histologically confirmed CD20-positive follicular non-Hodgkin's lymphoma, grade 1, 2 or 3a according to WHO 2017 classification.
- Age 18 ≥ years
- At least 2 prior systemic therapies for follicular lymphoma including both any antibody directed against the CD20 antigen and a chemotherapy combination.
- Treatment indications, with the presence of at least one of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Key exclusion criteria (18 listed)
- Grade 3b follicular non-Hodgkin's lymphoma or evidence of transformation to high-grade non-Hodgkin's lymphoma.
- Central nervous system or leptomeningeal involvement by lymphoma.
- Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent.
- Seropositivity for HBV or evidence of active infection (HBsAg positivity, or HBsAg negativity with positive anti-HBs/anti-HBc and detectable viral DNA load); if viral load is negative or undetectable, the patient is eligible, provided their HBsAg negativity.
- Positive viral HCV RNA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdelalisibIdelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma | Drug | Idelalisib Plus Obinutuzumab |
| ObinutuzumabIdelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma | Drug | Idelalisib Plus Obinutuzumab |
Primary outcome
Primary Endpoint - Overall Response Rate (ORR)
Time frame: Six months after the start of treatment
Investigator's assessed Overall response rate at the end of induction phase of patients treated with a chemo-free combination with obinutuzumab and idelalisib. Overall response rate is defined as the proportion of patients with at least a partial response according with 2014 Lugano criteria.
3 secondary outcomes
Secondary Endpoints 1 - Overall Survival (OS) Rate
Time frame: Up to 24 months from the start of treatment
Secondary Endpoints 2 - Progression-free Survival (PFS) Rate
Time frame: Up to 24 months from the start of treatment
Secondary Endpoints 3 - Patients' Withdrawal Rate
Time frame: Up to 24 months from the start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierluigi Zinzani, Prof. principal investigator
Bologna - Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Idelalisib and Obinutuzumab in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint - Overall Response Rate (ORR) (time frame: Six months after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.